1. Field of the Invention
This invention relates to disposable enema nozzles and more particularly to nozzles with adhesive means for securing the conduit to the body during the enema procedure. Still more particularly, the invention relates to an enema nozzle having an attached external positioning means that permits the technologist to adjust the insertion length of an enema tube.
2. Description of the Related Art
Enema tubes that are conventionally used in medical procedures such as administration of a barium enema for radiological examination, intrarectal administration of medicine, or other procedures where the tube necessarily remains in place for a period of time, typically comprise a smooth rigid or flexible tip or a tip with an inflatable retention cuff. Tips of these types are available, for example, from Lafayette Pharmaceuticals Incorporated, Lafayette, Ind.
Problems are frequently encountered with traditionally used enema tubes particularly when left in place for an extended period of time. Such problems include expulsion of the tip prior to completion of the procedure. Expulsion can occur due to pressure arising from colonic resistance due to distension by the enema fluid or from the opposing natural flow of intestinal contents. Also, some types of enema tubes can be easily dislodged while the technologist is positioning the patient or by the patient's movements during the procedure. This is frequently the case with pediatric patients, particularly infants. Additionally, in some patients, particularly infants and the elderly, the anal sphincter is functionally unable to retain the tip or to close tightly around the tip. As a result, leakage of the enema fluid commonly occurs, often causing insufficient colonic filling. Imperfect procedural results may be obtained as a consequence, or an insufficient dosage of medicine may be received by the patient. Another drawback of known enema nozzles having inadequate securing means is that they can travel too far into the patient's rectum. A particular concern with pediatric patients, who commonly move about during the enema procedure, is avoiding having the tube rupture a fragile rectum wall. Infants expecially have highly variable colonic dimensions which defy uniform treatment methods and materials.
Various prior art devices which employ a contoured region at some point along the tip for engaging the anal sphincter have been developed to deal with the problems of expulsion and fluid leakage around the tip. One such device is described, for example, in U.S. Pat. No. 4,325,370 to Young which discloses a locking groove on the enema tip in combination with a waist band and strap assembly to deter expulsion of the tip and prevent the tip from inappropriate insertion. Such a device is intended to be convenient for a patient to self-adjust, and anticipates that the technologist would then complete the attachment of the enema conduit. While devices such as Young's are an improvement for some patients over an unsecured enema tip, these devices are most appropriate for use with cooperative older children or adult patients. Elderly patients, for example, might find such assemblies uncomfortable or too difficult to adjust. Others, including the very young patient or the infirm, would be unable to use such assemblies. The technologist could be expected to have considerable inconvenience and expenditure of time putting such a device on the patient. Also, various sizes of the waistband/strap device would be needed to accommodate infant through adult-size patients.
Prior art methods simply incorporating an insertable retaining means on the tube, such as by modification of the contour of the tube's insertion end, or by putting an inflatable cuff or balloon on the tube end improves retention in some patients. However, inflation of the balloon in the patient's rectum typically causes discomfort. One such internal retention means is shown, for example, in U.S. Pat. No. 3,990,448 to Mather et al. which discloses a tapered head on the proximal tube end made large enough to deter expulsion and a retaining shoulder on the tube shaft, between which the anal sphincter of an average person is received.
Others have employed anal plugging means attached to the enema tube along with an external securing means to address the leakage, tube shifting and tube dislodging problems. For example, U.S. Pat. No. 3,575,160 to Vass et al. discloses an enlarged tapered head on the end of the inserted tube, a conical stud (located about midway along the tube) which fits within and seals the anal opening, and a plate attached to the stud which engages the bony outlet of the pelvis around the anus and engages the muscular-skin raphe in the cleft space between the buttocks.
While the existing art devices described above address to some degree the leakage and expulsion problems, and some prior devices also comprehend the problem of preventing the tip from being inserted too far into the rectum, they nevertheless have significant drawbacks. For example, most devices are designed to accommodate an average person and do not adequately provide for procedures on infants, very young children, the infirm or many geriatric patients or others without interactive anal muscles. The danger of bowel injury as a result of the enema tube's moving out of position and going too far into the rectum during a procedure is a continuing problem with some devices. There is also the risk with devices employing an inflated cuff of rupturing a fragile rectal wall. Infants, the elderly and others with insufficient rectal wall resiliency are particularly at risk. Use of an inflatable cuff in children under 10 years of age is generally not recommended by those of skill in the art. Even the best commonly used leakage-deterring devices for holding an enema tube in place for the duration of a medical procedure continue to have drawbacks including being uncomfortable or inconvenient for the patient, being excessively time consuming or being cumbersome for the technologist to use. Other devices are uneconomical, and do not adequately provide for wide variance in patient age, physical condition, ability to cooperate and so forth.
In present day practice the methods used by radiology staff typically include using a standard flexible tube, or tip, with a slightly rounded and enlarged head and, prior to insertion of the tip, wrapping one end of each of several strips of surgical tape around the tube at the most suitable position (as estimated by the technologist from age and condition of the patient and the buttocks size). This is followed by inserting the tube and, while the technologist holds the tube in the appropriate position, applying the dangling free ends of the tape strips to the patient's buttocks. One problem frequently encountered includes tangling of the tape strips during placement of the enema tube. Another problem is that once the tube is in place there is no convenient way to readjust placement of the tape wrapped around the tube without removing the tube. Disposable enema nozzles are needed which can be conveniently secured to the patient and which can avoid at least some of the above-described failings of prior art devices.